Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FDF 2023-09-15

Ambu® aScope Colon; Ambu® aBox 2

Applicant Ambu A/S

K-Number K230332

View Details →

CHL 2023-09-15

i-STAT G3+ cartridge with the i-STAT 1 System

Applicant Abbott Point of Care, Inc.

K-Number K223857

View Details →

BSO 2023-09-15

Perifix FX Catheter; Contiplex FX Catheter

Applicant B.Braun Medical, Inc.

K-Number K231242

View Details →

DQK 2023-09-15

Sensis Vibe (VD15)

Applicant Siemens Medical Solutions USA, Inc.

K-Number K223812

View Details →

NKB 2023-09-15

NIDO Pedicle Screw System

Applicant Kalitec Medical

K-Number K230974

View Details →

ITI 2023-09-15

Power wheelchair (Model:BC-EA8000)

Applicant Ningbo Baichen Medical Devices Co., Ltd.

K-Number K232121

View Details →

NHA 2023-09-15

BTI Dental Implant System UnicCa® Aesthetic Post Abutments

Applicant B.T.I. Biotechnology Institute, Sl.

K-Number K231827

View Details →

FOZ 2023-09-15

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter

Applicant Medsource International, LLC

K-Number K223788

View Details →

GYB 2023-09-15

Avologi Gel Primer (Model: Av25)

Applicant Premier North America, Inc.

K-Number K220735

View Details →

DWJ 2023-09-15

Barrier EasyWarm Active Self-Warming Blanket

Applicant Molnlycke Health Care Us, LLC

K-Number K232508

View Details →

HWC 2023-09-15

Accelerate Compression Screw System-Small Product Code ACC-S; Accelerate Compression Screw System-Medium Product Code ACC-M; Accelerate Compression Screw System-Large Product Code ACC-L

Applicant Trax Surgical

K-Number K230946

View Details →

JZO 2023-09-15

Elecsys Anti-Tg

Applicant Roche Diagnostics

K-Number K222610

View Details →

Page 718 of 2685

↑